Yan 2011.
Methods | Multiple‐centre (Beijing, Shanghai, Wuhan and Guangzhou), prospective, randomised, controlled trial Dates the study was conducted: not reported Funding sources and potential conflicts of interest: no information reported Definition of compliance: not reported |
|
Participants | Number and type of participants: 624 H.pylori‐positive participants were enrolled in the study Participants were randomised to 2 different treatment groups: 10‐day standard triple regimen and 10‐day sequential regimen Number of participants randomised: 622 (ITT sample) Number of participants in the 10‐day STT arm: 281 Number of participants in the 10‐day SEQ arm: 341 PP sample: not reported Country: China Average age (SD) of the population in years: not reported Sex (M/F) of the population: not reported Authors reported that there were no differences in age or BMI between treatment groups Medical condition at baseline: not reported H. pylori diagnostic methods in all treatment arms: histopathology Warthin‐Starry (WS) stain and RUT |
|
Interventions | Participants randomised to the SEQ group were administered tinidazole Length of STT (days): 10 Name, dose timing of antibiotics in 10‐day STT: esomeprazole 20 mg twice a day + clarithromycin 500 mg twice a day + amoxicillin 1 g twice a day (during 10 days) Name, dose timing of antibiotics in 10‐day SEQ: esomeprazole 20 mg twice a day + amoxicillin 1 g twice a day (during 5 days) and esomeprazole 20 mg twice a day + clarithromycin 500 mg twice a day + tinidazole 500 mg twice a day (during 5 days) (Total: 10 days) Sensitivity test (yes/no) to antibiotics before/after treatment: not reported Method of assessment of H. pylori status both before and after treatment: ¹³C‐UBT and histology WS stain Time for assessment of H. pylori status after treatment: 4 ‐ 12 weeks |
|
Outcomes | ITT eradication rate (%) by treatment group:
PP eradication (%) by treatment group were not reported Metronidazole resistance (%) before treatment, SEQ ITT/PP: not reported Metronidazole resistance (%) before treatment, STT ITT/PP: not reported Clarithromycin resistance (%) before treatment, SEQ ITT/PP: not reported Clarithromycin resistance (%) before treatment, STT ITT/PP: not reported Compliance: not reported Incidence of AEs at PP analysis in the total population: not reported Incidence (%) serious AEs SEQ / STT: not reported |
|
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | The study was reported as "randomised", no additional information was given |
Allocation concealment (selection bias) | Unclear risk | Risk is unclear |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Risk is unclear |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Risk is unclear |
Publication format | High risk | Abstract |